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FDA 510(k)

Pleurx Pleural Catheter System

K-Number: K160450 · 2016-10-31

ApplicantCare Fusion
Decision Date2016-10-31
Product CodeDWM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pleurx Pleural Catheter System is a medical device manufactured by Care Fusion. It received FDA 510(k) clearance on 2016-10-31 under approval number K160450. The device is classified under product code DWM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pleurx Pleural Catheter System?

Pleurx Pleural Catheter System is a medical device that received FDA 510(k) clearance on 2016-10-31. It is manufactured by Care Fusion. The 510(k) number is K160450.

When was Pleurx Pleural Catheter System approved by the FDA?

Pleurx Pleural Catheter System received FDA 510(k) clearance on 2016-10-31, under approval number K160450.

What company makes Pleurx Pleural Catheter System?

Pleurx Pleural Catheter System is manufactured by Care Fusion.

What is the FDA product code for Pleurx Pleural Catheter System?

The FDA product code for Pleurx Pleural Catheter System is DWM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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